Medical Action Industries Recalls Midline Insertion Kits Due to Package Integrity
Medical Action Industries is recalling 110 cases of Midline Insertion Kits because a component may have a package integrity breach.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator."
Plain-English summary
Medical Action Industries, Inc. is recalling 110 cases of Midline Insertion Kits (Part Number 77981B). The recall is due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
The affected kits were distributed nationwide to Ohio, Oregon, Florida, and California. The recall includes specific lot numbers with expiration dates ranging from July 2021 to April 2022.
Consumers and healthcare facilities should check their inventory for the specific part number and lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Kit: Midline Insertion DA. MAI Kit Part Number: 77981B
- Manufacturer
- Medical Action Industries, Inc. 306
- Category
- Medical Device — Surgical Kits
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Kit Number: 77981B
- UDI (GTIN): 20809160284053
- Lot Number: 0000281502 (Expiration Date: 04/08/2022)
- 0000282039 (Expiration Date: 04/08/2022)
- 0000274390 (Expiration Date: 07/09/2021)
- and 0000279101 (Expiration Date: 11/13/2021)
Distribution
Part of a larger recall action
This product is one of 6 recalled by Medical Action Industries, Inc. 306 under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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